Defective Drugs

Although we are fortunate to have access to numerous medications intended to keep us well, every drug comes with some risk. That fact is hard to remember when we watch heart-warming, pharmaceutical commercials or read glossy ads promising renewed health and eternal well-being. These ads for prescription medications seem to be working and drug manufacturers are reaping the rewards.
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In fact, prescription drugs accounted for $328.6 billion of national health-related spending in the United States in 2016.(1) According to the Centers for Disease Control and Prevention (CDC), “In 2015–2016, 45.8% of the U.S. population used prescription drugs in the past 30 days.”(2)

New drugs can bring new risks for people who take them. Adverse drug events (ADEs) can lead to serious medical complications or death.

In July 2018, a 9-year study (2006 to 2014) of the U.S. Food and Drug Administration (FDA) Adverse Events Reporting System database found 902,323 serious outcomes were reported to the FDA, including 244,408 deaths and 72,141 disabilities. (3)

New drugs must be approved by the FDA before they are sold. However, problems may still occur at any time — before, during, or after the approval process. In fact, many FDA-approved drugs have been linked with serious medical complications.

This is because drugs are tested only in a limited number of studies before being approved for the market. For this reason, it is important for patients and physicians to report drug adverse event to the FDA when such occur.

If you suffered severe complications or were hospitalized due to an adverse drug event, or if a relative died due to prescription drug-related complications, you may want to discuss your legal options with a knowledgeable attorney.

Weitz & Luxenberg may be able to help. We invite you to call us for a free consultation (855) 274-5624.

Consult your doctor before stopping any prescribed medication.

How Are Drugs Approved?

In 1938, Congress enacted the Food, Drug, and Cosmetic (FDC) Act. Since then, the drug approval process has continued to evolve.

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In 1962, a sleeping pill called thalidomide, not approved for use in the U.S. due to efforts taken by Dr. Frances Kelsey at the FDA, resulted in thousands of babies being born with birth defects in Western Europe after their mothers had taken the drug during pregnancy. In response, Congress approved legislation requiring drug manufacturers to demonstrate to the FDA that any new drug is safe and effective for its intended use before selling it in the U.S.(4)

To secure FDA approval, drug manufacturers must conduct limited laboratory, animal, and clinical tests to determine how new drugs work and whether they are safe for use in humans.

A team at the FDA’s Center for Drug Evaluation and Research (CDER) composed of doctors, chemists, and other scientists reviews the evidence from these limited tests. If this group of FDA employees determines results presented from this testing demonstrate a level of safety and a measurable health benefit, the FDA may approve the drug.(5)  In some cases, especially for particular classes of drugs, the FDA may approve a drug with the stipulation that additional postmarketing testing be conducted or that postmarketing safety monitoring of particular adverse events be performed by the manufacturer.(6) (7)

dividing tray with prescription drugs

Potential Risks from New Drugs

Sometimes the tests do not reveal all the potential risks of a new drug. In addition, in some cases, drug manufacturers fail to present all their evidence, submit erroneous or falsified information, fail to report adverse events or other study protocol violations, or fail to protect the safety of clinical trial patients.(8)

In addition, drug manufacturers may not communicate the risks of a drug to the public, even if the FDA discovers a problem at a clinical trial site during an inspection or after a medical journal publishes the results of a clinical trial. In fact, sometimes the problems can be substantial enough to cause or contribute to serious medical complications or even death.

Somewhere down the line, the FDA may require updated label instructions or warnings for complications, but, by then, the damage may have already been done. For some patients, the warning may come too late.

Adverse effects of medicines have spawned thousands of lawsuits in recent years.

elmiron eye issues

Elmiron (Pentosan Polysulfate Sodium)

Elmiron (pentosan polysulfate sodium) is approved by the FDA to treat interstitial cystitis. (9)

Interstitial cystitis is a chronic, regional pain syndrome affecting the bladder and pelvis. Nationwide, over 1 million people are estimated to have this condition. (10)

Interstitial cystitis is diagnosed in women more often than men. Symptoms may include urinary urgency, frequent urination, chronic pelvic pain, and painful sexual intercourse. (11)

In recent years, alarming reports about Elmiron eye- and vision-related adverse events have emerged. Pentosan polysulfate sodium may lead to a specific type of vision loss known as pigmentary maculopathy. (12) (13)

Elmiron may damage a person’s retina, especially the central portion, known as the macula. A healthy, intact retina is critical for helping people to see clearly and accurately, and the macula is essential to see details of near objects. (14)

Recent studies link longer-term use of Elmiron to a specific type of retinal eye damage. This condition is called pigmentary maculopathy. (15) (16) (17)

Symptoms of pigmentary maculopathy may include: (18) (19)

  • Blurred vision.
  • Difficulty reading.
  • Prolonged dark adaptation.
  • Metamorphopsia.

Metamorphopsia is a specific kind of perceptual distortion where linear objects appear curved or discontinuous. (20)

Elmiron eye damage complications are thus far believed to be irreversible. (21)

Patients taking Elmiron who develop drug-induced pigmentary maculopathy may be misdiagnosed as having pattern dystrophy or macular degeneration. (22)

 

How Weitz & Luxenberg Can Help

For more than 30 years, Weitz & Luxenberg has been at the forefront of complex product liability-related litigation. Our attorneys have secured more than $17 billion in awards and settlements for clients.

Although past results are no guarantee of future success, Weitz & Luxenberg possesses the experience and resources necessary to pursue justice for clients harmed by the negligence of large drug companies.

If you have been injured by a defective drug, we can help you understand your legal options, beginning with a free consultation. Call us at (855) 274-5624 or fill out the form on this page. One of our representatives will be in touch with you shortly.

  1. Hartman, M., et al. (2018, January). National Health Care Spending in 2016: Spending and Enrollment Growth Slow After Initial Coverage Expansion. Retrieved from https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2017.1299
  2. Centers for Disease Control and Prevention. (May 2019). Prescription Drug Use in the United States, 2015-2016. NCHS Data Brief No. 334: Retrieved from https://www.cdc.gov/nchs/products/databriefs/db334.htm#targetText=In%202015%E2%80%932016%2C%2045.8%25%20of%20the%20U.S.%20population%20used,and%20among%20males%20and%20females
  3. Sonawane, K.B., et al. (2018, July). Serious Adverse Drug Events Reported to the FDA: Analysis of the FDA Adverse Event Reporting System 2006-2014 Database. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/29952714
  4. U.S. Food & Drug Administration. (2014, December 19). About FDA. Significant Dates in U.S. Food and Drug Law History. Retrieved from http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm128305.htm
  5. U.S. Food & Drug Administration. (2016, January 29). Development & Approval Process (Drugs). Retrieved from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
  6. U.S. Food & Drug Administration. (n.d.). Approved Risk Evaluation and Mitigation Strategies (REMS). Retrieved from https://www.accessdata.fda.gov/scripts/cder/rems/
  7. U.S. Food & Drug Administration. (2016, March 10). Accelerated Approval Program. Retrieved from https://www.fda.gov/drugs/resourcesforyou/healthprofessionals/ucm313768.htm
  8. Seife, C. (2015, April). Research Misconduct Identified by the US Food and Drug Administration. Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature. Retrieved from http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2109855
  9. Ferguson, T.J., et al. (2019, January 5). Chronic use of pentosan polysulfate sodium associated with risk of vision-threatening disease. Retrieved fromhttps://link.springer.com/content/pdf/10.1007/s00192-018-3850-9.pdf
  10. Hanif, A.M. & Jain, N. (2019, July 10). Clinical Pearls for a New Condition. Retrieved from https://www.reviewofophthalmology.com/article/clinical-pearls-for-a-new-condition
  11. Mayo Clinic. (2019, September 14). Interstitial cystitis. Retrieved from https://www.mayoclinic.org/diseases-conditions/interstitial-cystitis/symptoms-causes/syc-20354357
  12. Hanif, A.M. & Jain, N. (2019, July 10). Clinical Pearls for a New Condition. Retrieved from https://www.reviewofophthalmology.com/article/clinical-pearls-for-a-new-condition
  13. Pearce, W.A., et al. (2018, November). Pigmentary Maculopathy Associated With Chronic Exposure to Pentosan Polysulfate Sodium. Retrieved from https://www.aaojournal.org/article/S0161-6420(17)33695-3/fulltext
  14. American Academy of Ophthalmology. (n.d.). Macula. Retrieved from https://www.aao.org/eye-health/anatomy/macula-6
  15. Pearce, W.A. et al. (2018, November). Pigmentary Maculopathy Associated With Chronic Exposure to Pentosan Polysulfate Sodium. Retrieved from https://www.aaojournal.org/article/S0161-6420(17)33695-3/fulltext
  16. Hanif, A.M. & Jain, N. (2019, July 10). Clinical Pearls for a New Condition. Retrieved from https://www.reviewofophthalmology.com/article/clinical-pearls-for-a-new-condition
  17. Hanif, A.M., et al. (2019, September 5). Phenotypic Spectrum of Pentosan Polysulfate Sodium-Associated Maculopathy: A Multicenter Study. Retrieved from https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2749093
  18. Pearce, W.A., et al. (2018, November). Pigmentary Maculopathy Associated With Chronic Exposure to Pentosan Polysulfate Sodium. Retrieved from https://www.aaojournal.org/article/S0161-6420(17)33695-3/fulltext
  19. Hanif, A.M., et al. (2019, September 5). Phenotypic Spectrum of Pentosan Polysulfate Sodium-Associated Maculopathy: A Multicenter Study. Retrieved from https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2749093
  20. American Academy of Ophthalmology. (n.d.). Metamorphopsia. Retrieved from https://www.aao.org/BcscSnippetDetail.aspx?id=577e2a33-77b5-43e4-9691-a817cf06a0b9
  21. Ferguson, T.J., et al. (2019, January 5). Chronic use of pentosan polysulfate sodium associated with risk of vision-threatening disease. Retrieved from https://link.springer.com/content/pdf/10.1007/s00192-018-3850-9.pdf
  22. Hanif, A.M. & Jain, N. (2019, July 10). Clinical Pearls for a New Condition. Retrieved from https://www.reviewofophthalmology.com/article/clinical-pearls-for-a-new-condition

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